Hyperbaric Oxygen Therapy in Distal Radius Fractures: Can it Shorten Recovery Time and Increase Fracture Healing? (HBOTRadius)
Primary Purpose
Hyperbaric Oxygen Therapy, Recovery Time, Contrast Media
Status
Suspended
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hyperbaric Oxygen Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hyperbaric Oxygen Therapy focused on measuring microcirculation, O2c
Eligibility Criteria
Inclusion Criteria:
- distal radius fracture
- only one radius is fractured
- medical treatment within 72 hours after accident
- patient will receive surgical treatment (plate)
- patient received information letter and singed agreement
- patient is German-speaking
- patient is competent
- patient is over 18 years of age
Exclusion Criteria:
- pathologic fractures
- open fractures
- fractures with wide soft tissue damage, that affects surgical treatment
- surgical treatment after more than 72 hours after the accident
- diabetes mellitus, that need medical treatment
- patient has PAD
- previous surgery treatment on the fractured arm or refracture
- patient is not competent
- immune deficiency
- polytrauma
- patient with diseases of the lung (hypercapnia)
- patient with open Foramen ovale
- pregnant women
- patient with NYHA IV
Sites / Locations
- RWTH Aachen University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
With HBOT
Without HBOT
Arm Description
Patients, who receive hyperbaric Oxygen Therapy after their surgical treatment
Patients who receive the same surgical treatment of their radius fracture than the patients of the group "with HBOT", but no hyperbaric oxygen therapy (comparison group)
Outcomes
Primary Outcome Measures
functional outcome
The functional outcome is measured by microcirculation as parameter for wound healing, force of the treated hand and level of pain.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01365780
Brief Title
Hyperbaric Oxygen Therapy in Distal Radius Fractures: Can it Shorten Recovery Time and Increase Fracture Healing?
Acronym
HBOTRadius
Official Title
Identification of Microcirculation in Distal Radius Fractures After Surgical Treatment With and Without Hyperbaric Oxygen Therapy (HBOT)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Suspended
Why Stopped
nump
acceptence by patient too low
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project is meant to show wether the HBOT can fasten the recovery process after surgical treatment of distal Radius fractures. For this propose the microcirculation is measured, together with the level of pain on a visual analog scale (VAS) and the remaining force of the hand after surgery is examined. Furthermore the sonography with contrast medium which is long established for examination of organs of the parenchyma, is meant to be verified at the muscular-skeletal system in this project.
Detailed Description
This project investigates microcirculation in skin, muscle and bone after surgical treatment of distal Radius fracture with and without Hyperbaric Oxygen Therapy for detecting any benefit of the HBOT. In Hyperbaric Oxygen Therapy the patients breathes Oxygen from a mask in a pressure chamber with higher air pressure than normal atmospheric pressure wich is meant to increase the peripheric oxygen suppley in the healing tissue. The patients will receive 10 sessions of HBOT. The patients who are treated with HBOT are chosen randomly.
The microcirculation is measured as parameter for tissue damage and wound healing. It is registered by O2c, which works with measuring reflected lightwaves. It is strictly noninvasive and causes absolutely no pain for the patient. The measurement device consists of two small probes, which simply stick to the patient´s skin. There are 8 measurements in this study:
The first one shortly after the surgical treatment, then there will be one measuring appointment every week up to four week. Afterwards the patients hands will be measured in the 6th, 8th and 12th week after surgical treatment. In all measurements the healthy side will be measured as well for comparison. Additional the force fo both hands and the level of pain in the Visual Analogue Scale are evaluated.
Furthermore there will be a sonography with contrast medium in the first week after surgical treatment to indicate any increase of blood suppley after the HBOT and detect any wound healing complications.
Therefore this study will research on the one hand if there is a benefit to the HBOT for the often young and healthy patients of radius fractures to return earlier and more easily to their health condition. On the other hand this study is meant to establish the sonography with contrast medium as a examination method with little risks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperbaric Oxygen Therapy, Recovery Time, Contrast Media, Sonography
Keywords
microcirculation, O2c
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
With HBOT
Arm Type
Active Comparator
Arm Description
Patients, who receive hyperbaric Oxygen Therapy after their surgical treatment
Arm Title
Without HBOT
Arm Type
No Intervention
Arm Description
Patients who receive the same surgical treatment of their radius fracture than the patients of the group "with HBOT", but no hyperbaric oxygen therapy (comparison group)
Intervention Type
Procedure
Intervention Name(s)
Hyperbaric Oxygen Therapy
Intervention Description
The patients receive 10 sessions of HBOT in two weeks, starting on the day after the surgical treatment of their radius fracture. Each session lasts about one hour.
Primary Outcome Measure Information:
Title
functional outcome
Description
The functional outcome is measured by microcirculation as parameter for wound healing, force of the treated hand and level of pain.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
distal radius fracture
only one radius is fractured
medical treatment within 72 hours after accident
patient will receive surgical treatment (plate)
patient received information letter and singed agreement
patient is German-speaking
patient is competent
patient is over 18 years of age
Exclusion Criteria:
pathologic fractures
open fractures
fractures with wide soft tissue damage, that affects surgical treatment
surgical treatment after more than 72 hours after the accident
diabetes mellitus, that need medical treatment
patient has PAD
previous surgery treatment on the fractured arm or refracture
patient is not competent
immune deficiency
polytrauma
patient with diseases of the lung (hypercapnia)
patient with open Foramen ovale
pregnant women
patient with NYHA IV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Knobe, MD
Organizational Affiliation
Dpt. of Orthopedic Trauma, RWTH Aachen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hans-Christoph Pape, Univ.-Prof. MD FACS
Organizational Affiliation
Dpt. of Orthopedic Trauma, RWTH Aachen University
Official's Role
Study Chair
Facility Information:
Facility Name
RWTH Aachen University Hospital
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany
12. IPD Sharing Statement
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Hyperbaric Oxygen Therapy in Distal Radius Fractures: Can it Shorten Recovery Time and Increase Fracture Healing?
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